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Speaker Series Survey - The Need for Speed: Navigating the Complexities of Expedited Product Approval Pathways
1.
If the road to biopharmaceutical drug approval was truly a road, what vehicle would you select to usher your product from discovery to commercial launch?
Ferrari SF90
Sherman tank
Volvo XC90
Other (please specify)
2.
Please select all expedited programs that have been granted for programs/products that you’ve worked on (or are currently working on):
Fast Track Designation
Regenerative Medicines Advanced Therapy Designation
Breakthrough Therapy Designation
PRIME Designation
SAKIGAKE Designation
Accelerated Approval (FDA) / Conditional Approval (EMA)
Priority Review (FDA) / Accelerated Assessment (EMA)
Real-Time Oncology Review
Project Orbis
Other (please specify)
3.
In just a few words, please describe your successes and/or challenges with expedited programs. Alternatively, please list the specific aspects (of expedited programs) you are eager to learn more about.
